An IIPM and Arindam Chaudhuri's Initiative

IIPM Prof. Prasoon S Majumdar on 'No Control on Drugs Control'

We still do not have centralised record keeping system for drugs

New Delhi, India -- (ReleaseWire) -- 04/16/2012 -- Lately, India has been witnessing quite a progress in its pharmaceutical sector, especially in production of generic drugs. Not only there has been increase in number of big pharma players but also the production capacity has been growing at a brisk pace. The unholy nexus between medical practitioners and pharmaceutical companies and rampant corruption in drugs control have had a direct impact as a whole on the pharma business, which stands at a staggering annual turnover of Rs.20,000 crore. The manufacturing of spurious drugs have increased by leaps and bounds in recent years with World Bank estimating 35 per cent of the global production of counterfeit drugs emanating from India! Almost Rs.4,000 crore of the drugs produced in India are estimated to be spurious, that’s causing a havoc on the international market too, where it is exported. US has already taken steps by putting India in 301-watch threat list.

The problem to counter the menace of counterfeit drugs is compounded by the fact that the country shamefully lacks authentic data regarding drug and its usage. The Mashelkar Committee report, one of the most comprehensive in the recent times, that was draft ed to study corruption that the drug trade faced, had to rely on unconfirmed media reports. It is deleterious that in spite of our government spending 4.8 per cent of the GDP on health, there is hardly any commissioning on data, be it records on confiscations, periodic research on generic drugs production or its distribution through dealers and retailers! What comes as a shock is the fact that industry associations despite incurring huge economic losses have not yet demanded a system of maintaining centralised records.

Delhi is one of the hubs of counterfeit drugs and availability of empty capsules and fake tablets are abundant and that too at a fraction of the prescribed cost. It is obvious that the entire trade thrives because of a strong nexus between the administrators and manufacturers. And this is the prime reason behind lack of data. In 2011, Delhi Pharmaceutical Trust agreed to conduct a survey as a major drive towards data obtainment with an overall cost of Rs.15-20 lakhs. However, its mere survey called on by some NGO recommendations and not a comprehensive one by a major statistical institute or a one backed by the ministry of health. Further, this was one time survey and is not carried out periodically. Moreover, less than 20 per cent of the drug manufacturing licensees are inspected.

Drug control not only suffers from loopholes and intentional reluctance at manufacturing level but also at retail level. At retail level, majority of the medical shops are not provided with a mandatory pharmacist! The Mashelkar Committee too, though did not charge the Drug Control Department directly, but made clear claims that there is substantial non-uniformity in existing legislations. To compound the problem further, the recommendation of providing one inspector per 25 manufacturing units never got materialised.

In order to curb this menace, the Health Ministry should setup an independent body. It’s imperative to centralise all records of drug production and issue licenses from a central system which needs to be renewed periodically post a couple of surprise checks and audits. Spurious drugs not only kill the domestic market but also kill the international market besides killing millions across the globe.